A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven squamous cell carcinoma of the head and neck

- Recurrent disease OR metastatic disease at initial diagnosis or at recurrence

- Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent
chemotherapy and radiotherapy allowed

- No more than one prior regimen of chemotherapy or biologic therapy for metastatic
disease

- Recurrence after adjuvant or induction chemotherapy may have received one additional
course of chemotherapy or biologic therapy

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: Zubrod 0-2

- Life expectancy: At least 3 months

- WBC at least 3000/mm3

- Platelet count at least 100,000/mm3

- Hematocrit at least 30%

- Bilirubin no greater than 1.5 times normal

- SGOT/SGPT no greater than 1.5 times normal

- Creatinine no greater than 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile women must use 2 methods of effective contraception, 1 barrier and 1
hormonal, beginning at least 4 weeks before study and continuing during and for 1
month after study

- Men must use effective barrier contraception during and for 1 month after study

- No grade 2 or greater peripheral neuropathy

- No serious infection or other concurrent illness requiring immediate therapy

- Must be able to take oral medications

- No medical or social factors that would interfere with compliance

PRIOR CONCURRENT THERAPY:

- Any number of courses of one regimen of chemotherapy allowed

- No concurrent cytotoxic chemotherapy

- No concurrent radiotherapy